Effectiveness of Virtual Reality Vision Therapy - VERVE

Convergence Insufficiency Clinical Trial

— VRVT - VERVE  

Official title:

Effectiveness of Vision Therapy in a Virtual Reality Headset

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04691427
• Other study ID #: OMT-01
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 14, 2021
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: OculoMotor Technologies
• Contact: Chang Yaramothu, PhD
• Phone: 9735585456
• Email: cto[@]omtvr.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to see how well the treatment of a participant's eye coordination and/or focusing problems improves eye muscle responses and symptoms of eyestrain. We will use an entertainment device called a virtual reality headset to play a custom-designed video game to find out how well the treatment of binocular vision improves a participant's coordination and/or focusing problem. The virtual reality headset uses eye-trackers to monitor progress in a totally objective manner. Objective testing allows the doctor to determine the results without relying on a participant's ability to answer questions or respond verbally in any way. We will compare the results of a participant before and after playing the video game.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: August 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age 9 years and older

• CISS score = 16

• Best-corrected distance visual acuity of 20/25 or better in each eye

• Random dot stereopsis appreciation of 500 seconds of arc or better

• Parent or subject understands the protocol and is willing to enroll in the study

Exclusion Criteria:

• Constant strabismus at distance or near

• Vertical heterophoria = 2 ? at distance or near

• = 2 line interocular difference in best-corrected visual acuity

• Near point of accommodation > 20 cm in either eye as measured by push-up method

• Manifest or latent nystagmus

• Non-strabismic binocular vision and accommodative disorders associated with known disease of the brain

• Diseases known to affect accommodation, vergence, or ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, Parkinson disease

• Any ocular or systemic medication known to affect accommodation or vergence such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti-cholinergics, bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil)

• Inability to comprehend and/or perform any study-related test or procedure

Related Conditions & MeSH terms

• Convergence Insufficiency
• Ocular Motility Disorders

Intervention

Device:
• Virtual Eye Rotation Vision Exercises (VERVE)
A video game designed with elements of vision therapy will be delivered to participants utilizing consumer-available virtual reality headsets (VIVE Pro Eye).

Locations

Country	Name	City	State
United States	OculoMotor Technologies	Newark	New Jersey
United States	The Eye Institute at Salus University	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
OculoMotor Technologies	New Jersey Institute of Technology, Salus University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Fusional Vergence	Normal range is >15 Prism Diopters	up to 4 weeks post-therapy
Primary	Near Point of Convergence	Normal range is < 6 cm	up to 4 weeks post-therapy
Secondary	Convergence Insufficiency Symptom Survey (CISS)	Normal range is < 21 for adults and < 16 for pediatrics	up to 4 weeks post-therapy
Secondary	Vision Quality of Life with Time Survey (VisQuaL-T)	Normal range is > 2.5	up to 4 weeks post-therapy
Secondary	Core Elements of Gaming Experience Questionnaire	User experience rating	up to 4 weeks post-therapy